News - March 27, 2019

MDR & IVDR Implementation Rolling Plan – Latest Update

Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting of 14 February, the European Commission (EC) updated the ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play of the coming Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

In its February update, the EC reported new details regarding the current status of

  • EC’s communication activities
  • and on the nomenclature to be used in the future UDI database

The Rolling Plan is to be read in conjunction with the ‘MDR/IVDR roadmap’, produced by the Competent Authorities for Medical Devices project (CAMD) and the Commission, providing an overview of all the Commission’s and national competent authorities’ expected initiatives (including guidances) during the transitional period.

EUCOPE is one of the selected stakeholders to take part in the public meetings of the MDCG, as well as in certain specific subgroups. We ensure a continuous monitoring of the implementation period for these two crucial pieces of legislation.

Should you need more information, please contact Laurent Louette.